Other secondary efficacy variables reflecting IBS symptoms include daily assessments of abdominal discomfort/pain; abdominal bloating, the number and consistency of stools, straining at defecation, and feeling of incomplete evacuation.

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females

Official Title ICMJE

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation

Brief Summary

This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Unknown status

Estimated Enrollment ICMJE

360

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ICMJE

Inclusion Criteria:

Female from 18 to 65 years of age, inclusive

Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:

Improvement with defecation

Onset associated with a change in frequency of stool

Onset associated with a change in form (appearance) of stool

Negative serum and urine pregnancy tests

Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization

Exclusion Criteria:

Serious underlying diseases, including psychiatric disorders

Current history of conditions affecting bowel transit

Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection